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Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Stéphane Coutu, Centre Hospitalier Universitaire de Sherbrooke.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745081
First Posted: December 7, 2012
Last Update Posted: December 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stéphane Coutu, Centre Hospitalier Universitaire de Sherbrooke
  Purpose

Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects.

This study compares both agents in favoring cerebral relaxation during elective supratentorial procedures for tumor resection.

Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer side effects than 20% mannitol.


Condition Intervention Phase
Osmotherapy Intracranial Pressure Drug: 20% mannitol bolus administration Drug: Hypertonic saline 3% bolus administration Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy Between 20% Mannitol and 3% Hypertonic Saline, Given as a Bolus at the Beginning of Elective Supratentorial Craniotomy for Tumor Resection, in Favoring Cerebral Relaxation Evaluated by a Sub-dural Intracranial Pressure Measurement.

Resource links provided by NLM:


Further study details as provided by Stéphane Coutu, Centre Hospitalier Universitaire de Sherbrooke:

Primary Outcome Measures:
  • Sub-dural intracranial pressure [ Time Frame: In average 30-60 minutes after intervention, just before dura mater opening ]
    Sub-dural measure of intracranial pressure to evaluate cerebral relaxation


Secondary Outcome Measures:
  • Subjective evaluation of cerebral relaxation [ Time Frame: In average 30-60 minutes after intervention, just after dura mater opening ]
    Subjective evaluation by the surgeon of cerebral relaxation on a 4 point scale

  • Serum lactate [ Time Frame: In average 5-8 hours after intervention, upon arrival in the intensive care unit ]
    Serum lactate measurement to assess tissue perfusion during the procedure


Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mannitol
Bolus mannitol 20% at skin incision
Drug: 20% mannitol bolus administration
Experimental: Hypertonic saline
Hypertonic saline 3% at skin incision
Drug: Hypertonic saline 3% bolus administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective supratentorial craniotomy for tumor resection
  • Presumed preoperative diagnosis of : astrocytoma (any grade), meningioma (any sub-type) or cerebral metastasis (any primary neoplasm)

Exclusion Criteria:

  • Age < 18 years
  • Reintervention
  • Glasgow coma scale < 13
  • Emergency surgery or American Association of Anesthesiologists physical status class 4 or 5
  • Prone or lateral positioning
  • Hypo or hypernatremia (serum sodium below 135 or above 150 meq/L)
  • Osmotherapy (either mannitol or hypertonic saline) given in the last 24 hours
  • Congestive heart failure (LVEF < 40% or restrictive diastolic dysfunction on echocardiography)
  • Chronic renal failure (creatinine clearance < 30 ml/min)
  • Pregnancy
  • Obesity (BMI > 40)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745081


Contacts
Contact: Stéphane Coutu, MD, FRCPC 8193461110 ext 14950 stephane.coutu@usherbrooke.ca

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H5N4
Contact    18193461110      
Sponsors and Collaborators
Université de Sherbrooke
  More Information

Responsible Party: Stéphane Coutu, Principal study investigator, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT01745081     History of Changes
Other Study ID Numbers: Study on cerebral relaxation
First Submitted: December 5, 2012
First Posted: December 7, 2012
Last Update Posted: December 7, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs